QA Specialist II (Product Complaints)- Onsite

Collabera; Alameda (CA); On-site; USD 73,000 - 88,000; Full time

Job summary

A leading company in the medical devices industry is seeking a QA Specialist II for complaints management. The role entails overseeing complaint evaluation and documentation while ensuring regulatory compliance. With opportunities for career growth, this contract position is ideal for candidates with relevant experience and a solid background in quality assurance.

Qualifications

• 3-7 years of relevant experience in complaints handling for regulated products.
• Ability to work independently and good documentation practices.

Responsibilities

• Serve as SME for complaints management and process evaluation.
• Create and update complaint handling procedures.
• Maintain documentation for product complaints.

Skills

Documentation practices

Complaint handling

Regulatory guidelines

Education

Bachelor's or Master’s degree

Job description

QA Specialist II (Product Complaints) - Onsite

Join to apply for the QA Specialist II (Product Complaints) - Onsite role at Collabera.

Job Details

• Location: Alameda, CA 94502
• Industry: Medical Devices
• Duration: 6 months with potential extension
• Pay Range: $35.00/hr - $42.00/hr

Responsibilities

• Serve as SME for complaints management, excluding manufacturing QA.
• Handle complaints processing, evaluation, and reporting, not data entry.
• Create and update procedures within the complaint handling system.
• Perform CAPA, deviations, and evaluate complaints in line with regulatory guidelines.
• Maintain documentation and records for product complaints.

Qualifications

• Bachelor's or Master’s degree with 3-7 years of relevant experience.
• Experience in complaints handling for regulated products, preferably medical devices.
• Good documentation practices and ability to work independently.
• Preferred: Medical device complaint handling, familiarity with regulations, post-market surveillance experience.

Additional Information

• Seniority level: Entry level
• Employment type: Contract
• Job function: Quality Assurance